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The biotechnology or biological product sector of the pharmaceutical industry is at the forefront of the development of the most advanced and complex medicines and therapies today. Given the complexity of the field, biotech companies face strict regulations that require the highest levels of accuracy and quality standard. Any product deviation (planned or unplanned) from approved procedures potentially affects quality, and therefore, compliance.

Sometimes called an out-of-specification (OOS) result, a biological product deviation may occur during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. Effective control of every biological product deviation from material specifications and release specifications is an essential component of quality improvement and compliance.

How can MasterControl Product Deviations™ Software Benefit You?

The MasterControl deviations software solution automates and manages the documentation, investigation, and resolution of every biological product deviation from written procedures, including release specifications and material specifications. The software not only efficiently resolves a deviation, but uses the data collected as a basis for continuous quality improvement, which is also critical to FDA compliance.

MasterControl considers validation an integral part of our software solutions for FDA-regulated customers. Our "continuous validation" approach dramatically cuts the time, pain, and cost involved in validation, making it easier to validate future upgrades. MasterControl's continuum of products and services address different levels of validation needs based on individual risk assessment and product deviation.

Here's how the MasterControl software for biological product deviation addresses some of the major challenges that companies face when resolving planned and unplanned deviations.

Deviations Management Challenges

MasterControl Deviations™ Software System

Disconnected Deviations Processes

A paper-based or hybrid system, which consists of disconnected processes, faces a significant challenge in enforcing uniform incident response. The scope of a product deviation is usually focused on a single event, rather than a series of events over time. Because trends and patterns of occurrence remain hidden, the quality system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of biological product deviation from release specifications or material specifications over a 30-day timeframe, and consequently fail to alert managers about the need to investigate the deviation -- which can in turn require a corrective/preventive action (CAPA).

Connected Processes

MasterControl Deviations is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes, including CAPA, OOS, and electronic batch record management. This allows a biological product deviation to be correlated to nonconformances and customer complaints. MasterControl leverages the data collected for use in continuous quality improvement required by the FDA.

Poor Tracking of Deviations

It's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.

Automatic Tracking of Deviations

The system tracks all routing information and data entered into an electronic form, allowing the owner of the biological product deviation to identify bottlenecks and understand the sequence of events during processing.

Poor Turnaround

With a paper-based system, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that product deviation process involves a small group.

Faster Turnaround

The system tracks all routing information and data entered into an electronic form, allowing the owner of the biological product deviation to identify bottlenecks and understand the sequence of events during processing.

The Ultimate Product Deviation Management Software by Master Control

MasterControl Deviations is an ideal deviation management software solution for controlling product deviation incidents, for helping avoid their recurrence, for taking a proactive approach to continuous quality improvement, and for assuring FDA and GMP compliance. The software's key features are outlined below.

Best-Practice Form and Process : A pre-configured, multi-page form prompts participants to collect all relevant data and guides them through the process while allowing responsible personnel to make the appropriate decisions regarding product deviation. The form is automatically routed to the appropriate personnel and can be escalated if not processed in a timely manner. This best-practice form facilitates compliance with deviation-handling requirements of 21 CFR Part 211.

Four-Step Process with Electronic Approval Signatures: This best-practice workflow guides users through the entire process of resolving a biological product deviation, from the initiation through the investigation, resolution, and approval processes.

Integrated with CAPA Process: The MasterControl deviation control software can be integrated with MasterControl CAPA, so that serious deviations can immediately move on to the process of corrective/preventive (CAPA).

Integrated with Nonconformance Process: When integrated with MasterControl Nonconformance any deviation that results in a material nonconformance will automatically move to the nonconformance disposition process.

Form-to-Form Launching: A CAPA form or a nonconformance form can be launched directly from the deviation form. By the same token, a product deviation form can be launched from a control recipe form in the MasterControl Electronic Batch Records solution. MasterControl maintains the links so that a completed process can easily be reviewed to see what triggered it. Relevant information from the deviation form is automatically transferred to the launched form, reducing data entry and increasing accuracy. This integrated approach makes it easier to comply with 21 CFR Part 211 quality management requirements.

Analytics Reporting Tool: This built-in tool comes with a standard set of pre-configured reports that can be adjusted and customized by the user. Planned and unplanned deviations can be trended and analyzed by process, product, vendor, etc. These "data-mining" capabilities can provide important insight into quality issues affecting the product deviation system and serve as yet another starting point for CAPA.

FDA 21 CFR Part 11 Compliant System: As with all software developed by MasterControl, the product deviation software solution is fully compliant with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval, password expiration, encryption, and certification.

To Learn More on Product Deviation

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.